This medicine may also be used for other fungus infections of the skin as determined by your doctor.

Most forms of this medicine are available only with your doctor's prescription. Some forms are available without a prescription. However, your doctor may have special instructions on the proper use for your medical condition.

Before Using Xolegel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoconazole topical in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ketoconazole topical in the elderly. However, some elderly patients may be more sensitive to the side effects of this medicine.

Pregnancy

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of ketoconazole

This section provides information on the proper use of a number of products that contain ketoconazole. It may not be specific to Xolegel. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

For patients using the cream:

Apply enough cream to cover the affected and surrounding skin areas, and rub in gently.

To help clear up your infection completely, it is very important that you keep using the cream for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for up to several weeks. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

For patients using the foam:

Wash your hands before and after using this medicine.

Do not spray the foam directly on your hand because it will begin to melt as soon as it touches your skin. Instead, spray the foam into the cap of the medicine can or other cool surface. Then dip your fingertips into the foam to pick up small amounts of the medicine, and apply to the affected skin areas. Gently massage the foam into your skin until it disappears.

If you are treating skin areas with hair, such as your scalp, move any hair away so the foam can be applied directly to the affected skin.

This medicine is flammable. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the medicine can.

For patients using the gel:

Wash your hands before and after using this medicine.

Apply enough ketoconazole gel to cover the affected and surrounding skin areas, and rub in gently with your fingertips.

After applying this medicine, do not wash the affected area for at least 3 hours.

Cosmetics (makeup or sunscreens) may be used on the treated skin areas no sooner than 20 minutes after this medicine is applied.

This medicine may be flammable. Do not use it near heat, an open flame, or while smoking.

For patients using the 1% shampoo:

Wet your hair and scalp well with water.

Apply enough shampoo to work up a good lather and gently massage it over your entire scalp.

Rinse your hair and scalp with warm water.

Repeat application.

Rinse your hair and scalp well with warm water, and dry your hair.

For patients using the 2% shampoo:

Wet your hair and scalp well with water.

Apply the shampoo to the skin of the affected area and a wide margin surrounding this area.

Work up a good lather and leave it in place for 5 minutes.

Rinse your hair and scalp well with warm water, and dry your hair.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Adults—Apply to the affected area of the skin and the surrounding area once a day.

Children—Use and dose must be determined by your doctor.

For seborrheic dermatitis:

Adults—Apply to the affected area of the skin and the surrounding area two times per day.

Children—Use and dose must be determined by your doctor.

For foam dosage form:

For seborrheic dermatitis:

Adults—Apply to the affected area of the skin and the surrounding area two times per day for 4 weeks.

Children—Use and dose must be determined by your doctor.

For gel dosage form:

For seborrheic dermatitis:

Adults, teenagers, and children 12 years of age and older—Apply to the affected area of the skin and the surrounding area once a day for 2 weeks.

Children younger than 12 years of age—Use and dose must be determined by your doctor.

For 1% shampoo dosage form:

For dandruff:

Adults—Use every 3 or 4 days for up to 8 weeks. Then use only as needed to keep dandruff under control.

Children—Use and dose must be determined by your doctor.

For 2% shampoo dosage form:

For pityriasis versicolor:

Adults—Use once.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Xolegel

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by this medicine.

Do not use this medicine for a skin problem that has not been checked by your doctor.

If your skin problem does not improve within 2 weeks for cutaneous candidiasis, pityriasis versicolor, tinea corporis, or tinea cruris; or 4 weeks for seborrheic dermatitis; or 4 to 6 weeks for tinea pedis, or if it becomes worse, check with your doctor.

Good health habits are also required for patients using the cream form of this medicine to help clear up your infection completely and to help make sure it does not return.

For patients using the cream for athlete's foot (tinea pedis; ringworm of the foot), the following instructions will help keep the feet cool and dry:

Avoid wearing socks made from wool or synthetic materials (e.g., rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot.

Wear sandals or well-ventilated shoes (e.g., shoes with holes).

Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder between the toes, on the feet, and in socks and shoes one or two times a day. It is best to use the powder between the times you use the cream.

If you have any questions about these instructions, check with your doctor.

For patients using the cream for ringworm of the groin (tinea cruris; jock itch), the following instructions will help reduce chafing and irritation and will also help keep the groin area cool and dry:

Avoid wearing underwear that is tight-fitting or made from synthetic materials (e.g., rayon or nylon). Instead, wear loose-fitting, cotton underwear.

Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder on the skin. It is best to use the powder between the times you use ketoconazole cream.

If you have any questions about these instructions, check with your doctor.

The foam form of this medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Tell your doctor if you have the following symptoms while using the ketoconazole 2% shampoo: hair discoloration, abnormal hair texture, removal of the curl from permanently waved hair, hair loss, itching, burning sensation of the skin, or blistering, peeling, or redness of the skin.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Xolegel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common—For cream, shampoo, foam, or gel

Itching, stinging, burning, or irritation not present before use of this medicine

red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts

skin dryness, pain, rash, redness, or swelling

sore in the mouth or on the gums

swelling of the face

Rare—For shampoo

Hair loss and irritation

Incidence not known—For gel

Pain

Incidence not known—For shampoo

Blistering, burning, crusting, dryness, or flaking of the skin

burning sensation of the skin

burning, itching, redness, skin rash, swelling, or soreness at the application site

discoloration of the hair

dry skin

fast heartbeat

fever

hives

hoarseness

irritation

itching, scaling, severe redness, or soreness of the skin

joint pain, stiffness, or swelling

rash

shortness of breath

swelling of the eyelids, face, lips, hands, or feet

thinning of the hair

tightness in the chest

troubled breathing or swallowing

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common—For shampoo or gel

Dryness or oiliness of the hair and scalp

headache

Rare—For shampoo

Abnormal hair texture

mild dryness of the skin

scalp pustules

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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